RhinoplastyFACE-QNCT03519100
Rhinoplasty and Quality of Life
An observational study of Rhinoplasty and Quality of Life, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Quality of life and satisfaction in aesthetic surgery is still under-evaluated. It is a prospective and multicenter study with a 4 months follow-up of patients under rhinoplasty or rhinoseptoplasty procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinoplasty, Quality of Life
- What is being tested?
- quality of life evaluation
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2018to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients will involved during surgery
Who may be able to join
- at least 18 years old,
- patient engaged for surgery procedure of rhinoplasty or rhinoseptoplasty
Who cannot join
- patient with nose surgery medical history,
- mental or physical incapacity to answer the questionnaires
- antecedent of cervico facial cancer
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UH Bordeaux
Bordeaux, 33000
HERON Antoine, 33 556795679 ext. 95475
de GABORY Ludovic
About this study
Official title: Rhinoplasty and Quality of Life: Prospective Multicenter Study Before and After Surgery
Quality of life and satisfaction in aesthetic surgery is still under-evaluated. It is a prospective and multicenter study with a 4 months follow-up of patients under rhinoplasty or rhinoseptoplasty procedure. They will answer to the FACE-Q and NOSE questionnaires before surgery, one week later and 4 months after the procedure. The aim of the study is to show a significant augmentation of the quality of life scores. At this occasion, the FACE-Q questionnaire has been translated and validated in French
Read the detailed description
The main objective of this study is to show the efficiency of the rhinoplasty or rhinoseptoplasty procedure on the quality of life in a French population. There are many Patients reported outcomes questionnaire in aesthetic surgery but none of them is perfect. The FACE-Q rhinoplasty modules questionnaires is a recent test which has been validated in English but not in French. It is able to evaluate different areas of the quality of life and patient satisfaction. After French validation of the FACE-Q, this study will compare patient satisfaction before and after rhinoplasty or rhinoseptoplasty procedure. There is a lack of studies in the French population about rhinoseptoplasty surgery and quality of life or satisfaction. The goal is to show the interest of a surgery procedure on the feeling of the patients, concerning very different domains of appearance. This could help us to define the preoperative patients who are able to be really improved by this surgery
- Conditions
- Rhinoplasty, Quality of Life
- Being tested
- quality of life evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life evaluationOther
quality of life evaluation post surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between the FACE-Q score
Change between the FACE-Q score at the inclusion, one week later and 4 months after surgery. The minimal clinical importance difference has to be determinate thanks to the validation process of the FACE-Q in French
Measured: at the inclusion, one week later and 4 months after surgery
Secondary outcomes (2)
Difference between the NOSE score
Difference between the NOSE score at the inclusion and 4 months after surgery
Measured: at the inclusion and 4 months post surgery
Difference between anthropometrics measures
Difference between anthropometrics measures of the nose before and after surgery
Measured: before and immediate post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start8 Jan 2018
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoplastyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- de GABORY Ludovic, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519100
- Sponsor's protocol ID
- CHUBX 2017/40
- Acronym
- FACE-Q
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2018
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhinoplasty and Quality of Life: Prospective Multicenter Study Before and After Surgery
- ClinicalTrials.gov ID
- NCT03519100
- Acronym / sponsor ID
- FACE-Q / CHUBX 2017/40
- Conditions
- Rhinoplasty, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Quality of life and satisfaction in aesthetic surgery is still under-evaluated. It is a prospective and multicenter study with a 4 months follow-up of patients under rhinoplasty or rhinoseptoplasty procedure. They will answer to the FACE-Q and NOSE questionnaires before surgery, one week later and 4 months after the procedure. The aim of the study is to show a significant augmentation of the quality of life scores. At this occasion, the FACE-Q questionnaire has been translated and validated in French
Detailed description
The main objective of this study is to show the efficiency of the rhinoplasty or rhinoseptoplasty procedure on the quality of life in a French population. There are many Patients reported outcomes questionnaire in aesthetic surgery but none of them is perfect. The FACE-Q rhinoplasty modules questionnaires is a recent test which has been validated in English but not in French. It is able to evaluate different areas of the quality of life and patient satisfaction. After French validation of the FACE-Q, this study will compare patient satisfaction before and after rhinoplasty or rhinoseptoplasty procedure. There is a lack of studies in the French population about rhinoseptoplasty surgery and quality of life or satisfaction. The goal is to show the interest of a surgery procedure on the feeling of the patients, concerning very different domains of appearance. This could help us to define the preoperative patients who are able to be really improved by this surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients will involved during surgery
Key inclusion criteria (2 listed)
- at least 18 years old,
- patient engaged for surgery procedure of rhinoplasty or rhinoseptoplasty
Key exclusion criteria (3 listed)
- patient with nose surgery medical history,
- mental or physical incapacity to answer the questionnaires
- antecedent of cervico facial cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality of life evaluationquality of life evaluation post surgery | Other | – |
Primary outcome
Change between the FACE-Q score
Time frame: at the inclusion, one week later and 4 months after surgery
Change between the FACE-Q score at the inclusion, one week later and 4 months after surgery. The minimal clinical importance difference has to be determinate thanks to the validation process of the FACE-Q in French
2 secondary outcomes
Difference between the NOSE score
Time frame: at the inclusion and 4 months post surgery
Difference between anthropometrics measures
Time frame: before and immediate post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
de GABORY Ludovic study director
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinoplasty and Quality of Life, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HERON Antoine (33 556795679 ext. 95475, antoine.heron.med@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between the FACE-Q score (time frame: at the inclusion, one week later and 4 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.